Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJohn O'Toole

About this trial

Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80

Undergoing one of 3 procedure types: 1) 2 or more levels of MIS decompression (e.g., discectomy, foraminotomy, laminectomy); 2) 1-3 levels of MIS transforaminal lumbar interbody fusion (TLIF) (with or without additional levels of MIS decompression for no greater than 3 total operative levels); 3) 1-3 levels of anterior lumbar interbody fusion (ALIF) or MIS lateral lumbar interbody fusion (LLIF) accompanied by posterior percutaneous instrumentation at the same levels

Willing and able to give consent

Disqualifiers

Opioid tolerant at the time of the surgical procedure--defined as consuming greater than 30mg of morphine milligram equivalents (MME) daily (https://www.cdc.gov/drugoverdose/prescribing/guideline.html)

Presence of an indwelling pain device (e.g., intrathecal opioid pump, spinal cord stimulator, dorsal root ganglion stimulator)

Known allergy to bupivacaine, clonidine or similar local anesthetics

Indication for surgery other than degenerative disease (e.g., neoplasm, infection, trauma)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine

    Drug

    Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB

  • normal saline

    Drug

    normal saline in 30cc syringes administered using ESPB technique

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: InvestigationalExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inpatient opioid consumption

Mean per day inpatient opioid consumption in morphine milligram equivalents (MME)

Time frame
Every 1 day during inpatient admission up to 30 days

Secondary outcomes

1

Post-discharge opioid consumption

Total and per day mean postoperative opioid consumption after hospital discharge in MME as recorded in medication diary by patients

Time frame
14 days (+/- 7days) ,56 days (+/- 14 days) and 90 days (+/- 19) postoperatively
2

Postoperative opioid prescriptions filled

• Total MMEs of opioid prescriptions filled as found on the Illinois Prescription Monitoring Program website

Time frame
From hospital discharge to 90 days postoperatively
3

Length of hospital stay

Duration of hospital stay postoperatively measured in days as determined by the time at which each patient met discharge criteria

Time frame
From time of surgery to time discharge criteria met in hours, up to 2160 hours
4

Postoperative Urinary Retention (POUR)

Incidence of POUR measured as proportion of inpatient hospital days demonstrating the need for straight catheterization or foley placement

Time frame
Immediately post-surgery to discharge, up to 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John O'Toole

Lead sponsor

Rush University Medical Center

Sponsor institution